The Effects of Intra Aortic Balloon Pump Prior to Revascularization on Mortality of Patients With Acute Coronary Syndrome Complicated With Cardiogenic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- 30-day-Mortality
研究概览
简要总结
Prevalence of cardiogenic shock in acute coronary syndrome patients is reported at about 5-8% with high fatality. Revascularization approach has already known as the standard of care, but the usage of intra-aortic balloon pump (IABP) as mechanical circulatory support is still a controversy. IABP SHOCK II trial revealed that short-term mortality did not improved by IABP but there are several essential variabels related to mortality that are not considered in the study which are IABP initiation time and weaning protocol.This study aim to evalute the effect of IABP prior to revascularization on mortality of patients with myocardial infarction complicated with shock.
92 subjects will be enrolled in this randomized controlled trial into two groups, with and without IABP. IABP group will be receiving the intervention prior to revascularization. The primary outcomes to be sought are in-hospital and 30-day mortality after revascularization. IABP effects measured by various indicators such as Global Longitudinal Strain by echocardiography on the 1st and 3rd day, NTproBNP and ST2 level on the 1st, 3rd and 5th day, effective lactate clearance and ureum creatinine level on the 1st and 3rd day and will be compared between two groups. Continous variabel will be presented in mean ± deviation standard or median, and analized with Student's t test or Mann-Whitney U test as appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years old
- •Myocardial infarction patients complicated with shock
- •Willing to enroll in the study (signed consent)
排除标准
- •Age greater than 80 years old
- •Heart and lung resuscitation for more than 30 minutes
- •Cardiogenic shock onset >12 hours (if known) or >18 hours (if not known/patient presented in emergency department already with shock)
- •Mechanical complication of myocardial infarction
- •Moderate and severe aorta regurgitation
- •Peripheral artery disease making IABP unfeasible
- •Patients not receiving revascularization by percutaneous coronary intervention
- •Patients who died before IABP insertion
- •Care termination requested by family
结局指标
主要结局
30-day-Mortality
时间窗: 30 days
Mortality of patients 30 day after hospitalization
次要结局
未报告次要终点
研究者
Dafsah A. Juzar, MD
Interventional Cardiologist, Principal Investigator
Indonesia University
